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Randomized Trial to Improve Prescribing Safety During Pregnancy

^a Kaiser Permanente Colorado Clinical Research Unit, Denver, CO
^b School of Pharmacy, University of Colorado at Denver and Health Sciences Center, Denver, CO
^c Kaiser Permanente Colorado Pharmacy Department, Denver, CO
^d Colorado Permanente Medical Group, Denver, CO
^e School of Medicine, University of Colorado at Denver and Health Sciences Center, Denver, CO.

^_* Correspondence and reprints: Marsha A. Raebel, PharmD, Kaiser Permanente Colorado Clinical Research Unit, PO Box 378066, Denver, CO 80237-8066 (Email: marsha.a.raebel{at}kp.org).

Received for publication: 02/23/07; accepted for publication: 04/09/07.

Objective: This study sought to determine whether a computerized tool that alerted pharmacists when pregnant patients were prescribed U.S. Food and Drug Administration pregnancy risk category D or X medications was effective in decreasing dispensings of these medications.

Design: Randomized trial. Pharmacy, diagnostic, and laboratory data were linked to identify pregnant patients prescribed targeted medications. Women (n = 11,100) were randomized to intervention or usual care. Physicians and pharmacists collaborated on the intervention.

Measurements: The primary outcome was the proportion of pregnant women dispensed a category D or X medication. The secondary outcome was the total number of first dispensings of targeted medications.

Results: A total of 2.9% of intervention (n = 177) and 5.5% of usual care (n = 276) patients were dispensed targeted medications (p < 0.001): 1.8% of intervention (n = 108) and 3.9% of usual care (n = 198) patients were dispensed only category D medication(s); 0.9% of intervention (n = 54) and 1.2% of usual care (n = 58) patients were dispensed only category X medication(s); 0.2% of intervention (n = 15) and 0.4% of usual care (n = 20) patients were dispensed both category D and X medications (p = 0.05). This resulted in intervention patients receiving 238 dispensings of unique targeted medications and usual care patients receiving 361 dispensings of unique targeted medications (p = 0.03). The study was stopped primarily due to 2 false-positive alert types: Misidentification of medications as contraindicated in pregnancy by the pharmacy information system and misidentification of pregnancy related to delayed transfer of diagnosis information.

Conclusion: Coupling data from information systems with knowledge and skills of physicians and pharmacists resulted in improved prescribing safety. Systems limitations contributed to project discontinuation. Linking ambulatory clinical, laboratory, and pharmacy information to provide safety alerts is not sufficient to ensure project success and sustainability.